Alcohol, Psychoactive Drugs, Analgesics and Evaluation in Penetrating Abdominal Trauma

NCT07330349 | Recruiting

• 1 other identifier: 2020.1639
• Study Type: observational
• Target: 363
• Locations: 1 country
• Sites: 2

Brief Summary

This prospective observational study aims to evaluate whether alcohol consumption, psychoactive drug use, or prior administration of analgesics affects the clinical evaluation and surgical decision-making process in patients with penetrating abdominal trauma. The study will be conducted in two level I trauma centers in Cali, Colombia: a public university hospital and a private university hospital, both with high volumes of trauma patients and established protocols for non-operative management using serial physical examination. In many trauma centers, serial physical examination is used to safely identify patients who require surgical intervention. However, there is concern that intoxication or altered mental status may reduce the reliability of physical examination, potentially leading to unnecessary imaging studies, delays in surgical decision-making, or non-therapeutic laparotomies. Despite this concern, available evidence supporting these assumptions is limited. Patients older than 14 years with penetrating abdominal trauma who undergo clinical evaluation to decide on surgical intervention. Patients will be classified according to the presence or absence of alcohol consumption, psychoactive substance use, or prior analgesic administration. The primary outcome is the time from hospital admission to the decision for surgical intervention. Secondary outcomes include trauma severity, need for surgery, length of hospital and intensive care unit stay, complications, and mortality. By comparing patients with and without substance exposure across two different trauma care settings, this study seeks to determine whether serial physical examination remains a reliable and safe method for clinical decision-making in this population. The results may help optimize evaluation strategies, reduce unnecessary surgical procedures and diagnostic tests, and improve the standardization of care for patients with penetrating abdominal trauma.

Conditions

Abdominal Injuries; Alcohol Intoxication; Substance-related Disorders; Penetrating Abdominal Trauma

Keywords

Trauma decision making; Time to surgery; Penetrating abdominal trauma; Alcohol use; Psychoactive substances; Analgesic administration

Outcome Measures

Primary Outcomes (1)

• Time to surgical decision

  Time elapsed from hospital admission to the clinical decision to proceed with surgical intervention, measured in hours, based on standard trauma care assessment.

  Up to 28 days

Secondary Outcomes (5)

• Need for surgical intervention

  Up to 28 days

• Time to surgery

  Up to 28 days

• In-hospital mortality

  During hospitalization (Up to 28 days)

• Trauma severity

  28 Days

• Intraoperative bleeding

  28 days

Study Arms (1)

Patients with Penetrating Abdominal Trauma

Patients presenting with penetrating abdominal trauma who are evaluated and managed according to standard trauma care protocols, including immediate operative management or clinical observation with serial physical examination, as clinically indicated.

Other: Alcohol consumption; Other: Psychoactive substance use; Other: Analgesic administration

Interventions

Alcohol consumption OTHER

Alcohol consumption prior to hospital admission, identified through patient report, clinical assessment, or laboratory testing when available, and observed as part of routine trauma care, not assigned by the study.

Patients with Penetrating Abdominal Trauma

Psychoactive substance use OTHER

Use of psychoactive substances prior to hospital admission, identified through clinical history, physical examination, or toxicology screening when available, and observed without modification by the study protocol.

Patients with Penetrating Abdominal Trauma

Analgesic administration OTHER

Administration of analgesic medications prior to or during initial hospital evaluation as part of standard trauma care, not assigned, standardized, or modified by the study.

Patients with Penetrating Abdominal Trauma

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes patients aged 14 years and older presenting with penetrating abdominal trauma to two university-affiliated trauma centers in Cali, Colombia (one public and one private). Patients are evaluated and managed according to standard trauma care protocols, including immediate operative management or clinical observation with serial physical examination, as clinically indicated. The study assesses the impact of alcohol consumption, psychoactive substance use, and analgesic administration on the clinical evaluation process and surgical decision-making during hospitalization.

You may qualify if:

• Patients presenting to the emergency department with penetrating abdominal trauma.
• Age 14 years or older.
• Patients evaluated and managed according to standard trauma care protocols, including immediate operative management or clinical observation with serial physical examination, as clinically indicated.
• Patients admitted to the participating trauma centers during the study period.

You may not qualify if:

• Patients transferred from another institution after initial surgical intervention.
• Patients declared dead on arrival.
• Patients with incomplete or missing clinical data precluding assessment of outcomes of interest.

Sponsors & Collaborators

• Fundacion Clinica Valle del Lili: lead
• Hospital Universitario del Valle Evaristo Garcia: collaborator

Study Sites (2)

Fundación Valle del Lili

Cali, Valle del Cauca Department, Colombia

RECRUITING

Hospital Universitario del Valle Evaristo García

Cali, Valle del Cauca Department, Colombia

RECRUITING

MeSH Terms

Conditions

Abdominal Injuries; Alcoholic Intoxication; Substance-Related Disorders; Alcohol Drinking

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Wounds and Injuries; Alcohol-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Drinking Behavior; Behavior

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Central Study Contacts

Sergio I Prada Ríos, PhD

CONTACT

+57 6023319090; sergio.prada@fvl.org.co

Alberto F García, MD, MSc

CONTACT

+57 3154676870; alberto.garcia@fvl.org.co

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 28 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Trauma and Acute Care Surgeon

Study Record Dates

• First Submitted: December 29, 2025
• First Posted: January 9, 2026
• Study Start: November 25, 2020
• Primary Completion: December 24, 2025
• Study Completion: January 30, 2026
• Last Updated: January 9, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Upon completion of the analysis and for up to five years thereafter
• Access Criteria: Data will be shared on an individual basis with all individuals who make a reasonable request aimed at contributing to scientific knowledge

Locations

CO (2)